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2018/1/8 ~ 11Á|¦æªº²Ä¤­©¡AACR - IASLCÂù®p·|¤¤¡A©x¤èºô¯¸¤w¸g¤½¥¬¤F¡A¥_·¥¬PµoªíªºADI + Cisplatin+ Pemetrexed ªvÀø«D¤p²Ó­MªÍÀù (NSCLC)½×¤å¡Aµoªíªº®É¶¡¤w¸g½T©w¬°

Wednesday, January 10, 2018,5:40 p.m. ¦ý³o¬OSan Diego, California, USAªº®É¶¡

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Poster Session B Wednesday, January 10, 2018 5:40 p.m.¡V7:00 p.m. Legends 5¡V6 and Encore

B33 Expansion study of pegylated arginine deiminase (ADI-PEG20), pemetrexed and cisplatin in patients with ASS1-deficient non-squamous non-small cell lung cancer (TRAP). Peter Szlosarek, Barts Cancer Institute & Center, London, United Kingdom.

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2.Timing is critical; not necessarily wait for completion of pivotal studies

Engage major investment bank as financial advisor

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Roche and Ignyta reach definitive merger agreement

• Roche to acquire Ignyta for US$ 27.00 per share

• Ignyta¡¦s investigational medicine entrectinib, a selective CNS-active tyrosine-kinase inhibitor being developed for tumours that harbor ROS1 or NTRK fusions, to expand Roche¡¦s portfolio of oncology medicines

• Roche (SIX: RO, ROG; OTCQX: RHHBY) and Ignyta, Inc. (NASDAQ: RXDX) today announced they have entered into a definitive merger agreement for Roche to fully acquire Ignyta at a price of US$ 27.00 per share in an all-cash transaction. This corresponds to a total transaction value of US$ 1.7 billion on a fully diluted basis. This price represents a premium of 74% to Ignyta¡¦s closing price on 21 December 2017 and a premium of 71% and 89% to Ignyta¡¦s 30-day and 90-day volume weighted average share price on 21 December 2017, respectively. The merger agreement has been unanimously approved by the boards of Ignyta and Roche.

¡´¦]¬°Ignyta¾Ö¦³¤@Áû¤fªAªº±M¥´ROS1 fusions (¦ûNSCLCªº3%, ¥Ø«e¥ÎÃIJĤ@¥N¼Ð¹v¬OPfizerªºCrizotinib¡÷mPFS 10.4¤ë, ²Ä¤G¥N¼Ð¹v¬O¤é¥»ªZ¥ÐªºBrigatinib¤ÎNorvatisªºCeritinib)and TRK fusions (all solid tumor, ¦Ü¤Ö¦û©Ò¦³Tumorªº0.5%~1%, ©M¬Q¤Ñ¤À¨É³QBayer¨Ö±¼ªºLoxo¤@¼Ë¡I)ªºÃÄ¡÷entrectinib¡I

• Ignyta¡¦s lead molecule entrectinib is an orally bioavailable, CNS-active tyrosine kinase inhibitor being developed for tumours that harbor ROS1 or NTRK fusions. An ongoing pivotal phase 2 clinical trial will support, if successful, dual NDA submissions. Entrectinib targets tumours with one of two genetically defined gene rearrangements: ROS1 fusions in non-small cell lung cancer (NSCLC), and NTRK fusions across a broad range of solid tumours.

¡´entrectinib¥Ø«e¶i¦æ¨ìphase 2¡A¥B¤w±o¨ìEMAªºPRIME designation and FDAªº¬ð¯}©ÊÀøªk¡I³Ìªñªº¸ê®ÆÅã¥Ü¡÷¦bROS1 fusion-positiveªºadvanced NSCLCªvÀø¤W¡AORR=78%(25/32,¬ã¨sªÌµû¦ô)¡AORR=69%(22/32,¿W¥ß¤¤¤ßµû¦ô)¡A¤¤¦ì¤ÏÀ³´Á¬°28.6­Ó¤ë¡AmPFS¬°29.6­Ó¤ë¡A53%ªº¯f¤HÁÙ¦b«ùÄò±µ¨üªvÀø¤¤¡I¹ïBrain meta.ªºORR=83%(5/6,¿W¥ß¤¤¤ßµû¦ô)

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• In the recently announced interim data including patients from the STARTRK-2 trial in patients with ROS1 fusion-positive advanced NSCLC, entrectinib demonstrated a 78 percent (25 out of 32; by Investigator) and 69 percent (22 out of 32; by blinded independent central review, BICR) confirmed objective response rate (ORR). Entrectinib also showed a median duration of response of 28.6 months and median progression free survival of 29.6 months in this population, with 53 percent of patients remaining on study. Moreover, entrectinib showed 83 percent (5 out of 6 by BICR) confirmed intracranial ORR in patients with measurable brain metastases. Safety was consistent with previous studies of entrectinib. With over 200 patients treated at the recommended phase 2 dose, most adverse events (AEs) were Grade 1-2 and reversible, and only 3 percent of patients discontinued from the study due to treatment-related AEs. The program is tracking towards dual NDA submissions in NTRK tumour-agnostic and ROS1 NSCLC, if supported by clinical data, with an anticipated US commercial launch in both indications thereafter.

¡´NSCLC¬ù25%~30%¾A¥Î¼Ð¹v¡IRoche­ì¥»¦³EGFR(¦û¼Ð¹vªº60%¥ª¥k)ªºIressa, Tarceva¡BVEGF(¦û¼Ð¹vªº20%¥ª¥k)ªºAvastin¡B¤~­è¤£¤[ªºALK(¦û¼Ð¹vªº5%~6%¥ª¥k)ªºAlectinib¡B²{¦b¹w­p±N¨ÓªºROS1(¦û¼Ð¹vªº3%¥ª¥k)ªºentrectinib¡I¦ý¬OÃÄÃÒ¨ì´Áªº¡B³QÅú­¹ªº........

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next-generation sequencing (NGS), immunohistochemistry (IHC), polymerase chain reaction (PCR), and fluorescent in situ hybridization (FISH)

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Sanofi and Regeneron«Å§G¡AºX¤Uªºanti-PD1 therapy (cemiplimab)¹ïcutaneous squamous cell carcinoma(¥Ö½§Å쪬²Ó­MÀù)ªºpivotal results!!!

13 Dec 2017

Sanofi and Regeneron announce positive topline pivotal results for PD-1 antibody cemiplimab in advanced cutaneous squamous cell carcinoma

¡´2. RocheªºAlecensa (alectinib) EMA¦P·N¤F¹ïALK-positive NSCLC(¬ù¦ûªÍÀù5%)ªº¤@½u¥ÎÃÄÃÄÃÒ--------¦ý¬O¦³±o´N¦³¥¢¡÷¹ïRocheªºEGFR NSCLC(¬ù¦ûªÍÀù25%) 2/3½u¥ÎÃÄTarceva«o±N³QAstraZenecaªºTagrisso¨ú¥N¡I

Basel, 21 December 2017

European Commission approves Roche¡¦s Alecensa (alectinib) as first-line treatment in ALK-positive lung cancer

¡´3. FDA¦P·N¤FRocheªºPerjeta (pertuzumab)+ Herceptin® (trastuzumab)+ chemotherapy¥Î©ó¯S©w¦­´Á¨ÅÀù(HER2-positive)ªº³N¬q»²§U©ÊÀøªk(adjuvant treatment)¡C¦P®É§âPerjeta-based regimenªº«e¾É©ÊÀøªk(neo-adjuvant) Accelerated approval§ï¬°full approval for neoadjuvant (before surgery) treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than two centimetres in diameter or node-positive)¡I¡I¡I

Basel, 21 December 2017

FDA approves Roche¡¦s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer

• Accelerated approval of Perjeta for neoadjuvant use also converted to full approval

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the US Food and Drug Administration (FDA) has approved Perjeta® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (eBC) at high risk of recurrence.1 People should receive the adjuvant Perjeta-based regimen for one year (up to 18 cycles). The FDA has also converted the previously granted accelerated approval of the Perjeta-based regimen to full approval for neoadjuvant (before surgery) treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than two centimetres in diameter or node-positive). People receiving the neoadjuvant Perjeta-based regimen should continue Perjeta and Herceptin after surgery to complete one year of treatment.

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Wednesday - December 20, 2017

¡´«ô¦Õ+Loxo Oncology¬Q¤é«Å§G¡÷¹ïªvÀø©Ò¦³TRK fusion cancers¶W¦³®Äªºlarotrectinib¶}©l¦VFDA,EMA´£¥Xºu°Ê¦¡¥Ó½ÐNDA¡I´Á±æ¦b2018 Q1´N§¹¦¨©Ò¦³¥Ó½Ð¡I

Bayer announces initiation of rolling submission of new drug application in the U.S. for larotrectinib for the treatment of TRK fusion cancers

Completion of NDA submission expected in early 2018

Berlin, December 20, 2017 ¡V Bayer today announced that its collaboration partner Loxo Oncology, Inc. (Nasdaq: LOXO), a biopharmaceutical company based in Stamford, CT, has initiated the submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib. The NDA is being submitted for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments. Bayer and Loxo Oncology are jointly developing larotrectinib, an investigational compound being studied globally for the treatment of patients with cancers harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations present across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth. Loxo Oncology expects to complete the NDA submission in early 2018.

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US FDA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated non-small cell lung cancer

Acceptance follows FDA Breakthrough Therapy Designation

Tagrisso granted Priority Review

AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations). The FDA has granted Tagrisso Priority Review status and previously granted Breakthrough Therapy Designation in the 1st-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC.

The submission acceptance is based on data from the Phase III FLAURA trial, in which Tagrisso significantly improved progression-free survival (PFS) compared to current 1st-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC.

On 28 September 2017, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology were updated to include the use of Tagrisso in the 1st-line treatment of patients with metastatic EGFRm NSCLC. The use of Tagrisso in this indication is not yet approved by the FDA.

About Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases. Tagrisso 40mg and 80mg once-daily oral tablets have been approved in more than 60 countries, including the US, EU, Japan and China, for patients with EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being investigated in the adjuvant setting and in combination with other treatments.

About the FLAURA trial

The FLAURA trial assessed the efficacy and safety of Tagrisso 80mg once daily vs standard-of-care EGFR-TKIs (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in previously-untreated patients with locally-advanced or metastatic EGFR-mutated NSCLC. The trial was a double-blinded, randomised trial, with 556 patients across 29 countries.

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Best regards,

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¦Ñ´­10141055  µoªí®É¶¡:2017/12/15 ¤U¤È 12:10:57²Ä 2446 ½g¦^À³
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www.genetinfo.com/investment/featured/item/13149.html?start=6

Gºô¦³¾ã²zQ&A ¤F

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Good morning!

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Regorafenib is the only systemic treatment shown to provide survival benefit in HCC patients

progressing on sorafenib treatment. Future trials should explore combinations of regorafenib with other systemic

agents and third-line treatments for patients who fail or who do not tolerate the sequence of sorafenib and

regorafenib.

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Go go Polaris!!!

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In the CheckMate -040 trial, 14.3%* (95% CI: 9.2-20.8; 22/154) of patients responded to treatment with Opdivo. The percentage of patients with a complete response was 1.9% (3/154) and the percentage of patients with a partial response was 12.3% (19/154). Among responders (n=22), responses ranged from 3.2 to 38.2+ months; 91% of those patients had responses of six months or longer and 55% had responses of 12 months or longer.1 The median time to response was 2.8 months (range: 1.2-7.0).2 The overall response rate based on modified RECIST was 18.2% (95% CI: 12.4-25.2; 28/154). Complete response rate was 3.2% (5/154); partial response rate was 14.9% (23/154).1 Responses were observed across PD-L1 expression levels.2

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Opdivo ORR 14.3%(Recist),18.2%(mRecist)

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«ô¦Õ­è­èµo§G¤¤°ê¤j³°®Ö­ã¤FStivarga® (regorafenib)¬°Nexavar® (sorafenib)

¥¢±Ñ«áªº¨xÀù¤G½u¥ÎÃÄ¡I³o¬O²Ä¤@­ÓCFDA®Ö­ãªº¨xÀù¤G½u¥ÎÃÄ¡I®Ö­ãªº²z¥Ñ¬O¦]¬°Phase III RESORCE studyªºµ²ªG¡AStivarga mOS=10.6 monthsÀu©ó¹ï·Ó²ÕªºPlacebo= 7.8 months, (HR 0.62, 95% CI 0.50-0.78; p<0.0001).

Bayer receives approval in China for Stivarga® (regorafenib) for the second-line systemic Treatment of liver cancer

Approval based on data from the Phase III RESORCE study where Stivarga® (regorafenib) demonstrated significant improvement in overall survival in hepatocellular carcinoma (HCC) patients previously treated with Nexavar® (sorafenib)

Berlin, December 13, 2017 ¡V Bayer announced today that the Chinese Food and Drug Administration (CFDA) approved Stivarga® (regorafenib) tablets for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar® (sorafenib). The data from the pivotal Phase III RESORCE study showed that Stivarga® (regorafenib) provided a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo; the median OS was 10.6 vs 7.8 months, (HR 0.62, 95% CI 0.50-0.78; p<0.0001). Exploratory analyses of the RESORCE trial showed that the median time from the start of prior sorafenib treatment to death was 26 months in patients receiving regorafenib versus 19.2 months in those receiving placebo. Regorafenib is the first drug approved for the second-line treatment of patients with HCC in China. The CFDA approval expands Bayer¡¦s leadership in liver cancer with a treatment plan in HCC involving use of Stivarga directly after progression on Nexavar.

¨Ó¦^ÅU¤@¤UStivarga® (regorafenib) ªºPhase III RESORCE study§a~~

Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib

treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial

Lancet 2017 p-56-66

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Primary endpoint: OS

Secondary endpoint: PFS, TTP, ORR, DCR(CR, RR, SD¥²¶·¤j©óµ¥©ó6 wksªº¤~ºâ)

Tertiary endpoints: pharmacokinetics of regorafenib, and biomarker evaluation¤£¦b³o¤@½g°Q½×

safety: every cycle

Stivarga (regorafenib)379­Ó¯f¤H¯Ç¤J¦¹²Õ¡A¡´¥u¦³65¤H§¹¦¨ªvÀø¡´¡A309¤H¨S¯à§¹¦¨ªvÀø¡A­ì¦]¦p¤U¡G

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1 adverse event, 5 death, 26¤H¯f¤H¥D°Ê°h¥X, 2¤H¤£¿í±q¥ÎÃÄ, 1¤HÂå®v¨M©w, 1¤Hprotocol violation.

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CR=2¤H(1%)-----mRECIST; ¡´0¤H(0%)-----RECIST 1.1¡´

PR=38¤H(10%)-----mRECIST; ¡´25¤H(7%)-----RECIST 1.1¡´

SD=206¤H(54%)-----mRECIST; 223¤H(59%)-----RECIST 1.1

PD=86¤H(23%)-----mRECIST; 85¤H(22%)-----RECIST 1.1

ORR=40¤H(11%)-----mRECIST; ¡´25¤H(7%)-----RECIST 1.1¡´

DCR=247(65%)-----mRECIST; 249¤H(66%)-----RECIST 1.1

mOS=10.6¤ë---¦A²Ó¤À¦³³Ü°sªºsubgroup mOS=11.1¤ë, B¨xªºsubgroupmOS=8.8¤ë, C¨xªºsubgroupmOS=10.9¤ë

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Grade 3/4¡÷hypertension (57[15%], hand¡Vfoot skin reaction (47[13%], fatigue (34 [9%], and diarrhoea (12[3%].

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